đź“‹ FDA Reference
Alma Lasers Family of Pixel RF TIPS
Alma Lasers
Summary: The Alma Lasers Pixel RF Tips are used in dermatological and aesthetic procedures to improve skin texture and appearance. They are primarily used by dermatologists and cosmetic surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K121150 ↗
Decision Date ?
September 21, 2012
Product Code ?
GEI
Device Class ?
Class 2
Evidence ?
0 studies
The Alma Lasers Pixel RF Tips were cleared via the FDA 510(k) pathway on September 21, 2012. Manufactured by Alma Lasers, this device is classified as Class 2 under product code GEI.
What It Is
The Alma Lasers Pixel RF Tips are a family of fractional radiofrequency devices designed to deliver controlled thermal energy to the skin. This technology promotes collagen remodeling and skin rejuvenation. The device operates by creating micro-injuries in the skin, which stimulate the body's natural healing processes and improve skin texture and tone.
FDA-Cleared Indications
- Use in dermatological procedures that require fractional radiofrequency treatment of the skin.
- Skin resurfacing and rejuvenation as specified by the cleared device labeling.
Clinical Applications
- Fractional radiofrequency skin resurfacing
- Dermatologic treatment intended to improve skin texture
- Aesthetic skin rejuvenation procedures
- Treatment of selected superficial skin irregularities when performed within the device labeling
Practical Considerations
- The tips are used with compatible Alma Lasers systems; clinicians should confirm system and tip compatibility before treatment.
- Tip configurations and treatment areas may vary by model, so the applicable instructions for use should be reviewed for each tip.
- Treatment is generally performed on the skin with topical or local anesthesia, or other comfort measures, depending on treatment intensity and area.
- The device delivers radiofrequency energy rather than ionizing radiation and is not an MRI device; MRI compatibility should not be assumed for the handpiece, tips, or connected system.
- Patient selection, energy settings, infection control, eye protection when appropriate, and management of burns, pigment changes, scarring, and other skin injury risks require trained clinical personnel.
Frequently Asked Questions
What is Alma Lasers Pixel RF Tips used for?
The device is used for skin resurfacing and rejuvenation, improving skin texture, and reducing the appearance of wrinkles and scars.
What specialties typically use this device?
Dermatologists and cosmetic surgeons commonly use this device in aesthetic and dermatological procedures.
What are the FDA-cleared indications?
The device is indicated for dermatological procedures requiring skin resurfacing and rejuvenation, such as treating wrinkles and acne scars.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.